StemEnhance: The Rest of the Story

StemEnhance: The Rest of the Story

The following story first appeared as a Wellness Update on February 14, 2007. On February 24, 2007 I received a lengthy response from Christian Drapeau, the creator of StemEnhance. He assured me that he has research ready for publication that will demonstrate that StemEnhance continues to regularly stimulate bone marrow stem cell release when taken over a two year period. Unfortunately he expressed a total disregard for the potential toxicity of the product and a complete lack of appreciation of the manner in which bone marrow stem cells promote cancer growth and metastases. Mr. Drapeau's remarks are posted in their entirety following the original article, with my comments in blue.

StemEnhance: New Story, Old Risks?

Judging by the number of e-mails and phone calls I am receiving promoting the latest, greatest, cure-for-all-diseases, Stem Enhance is taking the nation by storm. Unfortunately, the main thing that is new about the product is its name. Within its carefully crafted marketing package are found extracts from a once highly profitable cure-all that saw its sales plummet after it was discovered that the product is prone to contamination with a potentially fatal liver toxin and carcinogen.

Stem Enhance is a product that supposedly increases the release of stem cells from the bone marrow. However, the ability of the product to produce a sustained release of stem cells has never been shown. Neither is there any evidence that an increased release of stem cells from the bone marrow is going to have a positive impact on a person's health.

The creation of Stem Enhance appears to be a ploy to boost the sagging sales of blue-green algae. At its peak in popularity blue-green algae boasted $400 million in sales annually and was claimed to be able to cure in excess of 600 diseases!

Stem Tech, unlike the original blue-green algae promoter Cell Tech, does not refer to the product as "blue-green algae" but by its scientific name "Aphanizomenon flos-aquae". Stem Tech also states that the product is comprised of extracts from the algae, rather than the whole plant.

My review of the medical literature on aphanizomenon flos-aquae revealed that 97 of 99 bottles of blue-green algae analyzed by independent researchers have been found to contain a microtoxin capable of causing liver failure. A wrongful death lawsuit involving a young girl who worked for Cell Tech and died of liver failure after taking their products is pending.

In February 2003 Cell Tech was found guilty of making 30 false, misleading, or deceptive claims and ordered to refund the full purchase price to any California customer who had bought the product between 1997 and 2002 if they requested a refund. That sort of publicity seriously affected Cell Tech's bottom line, so a new product name (Stem Enhance) with a new story line (enhanced stem cell release) was needed.

Stem Enhance appears to be the creation of Cell Tech's original Director of Research & Development, Christian Drapeau, who is now the Chief Science Officer for Stem Tech. Three additional former Cell Tech executives are part of Drapeau's "Desert Lake Technologies".

Drapeau, in collaboration with Gitte Jensen, first published a paper in the journal Medical Hypotheses. Medical Hypotheses is not a journal that shares data or facts; it is a forum for proposing theories. In the article Drapeau and Jensen state, "we propose the hypothesis that in situ mobilization of stem cells from the bone marrow and their migration to various tissues is a normal physiological process of regeneration and repair."

It is important to understand that what was stated is simply a theory. There is little evidence to support the hypothesis. It is true that a few autopies of individuals who have died following bone marrow transplants have found an occasional somatic (non-blood) cell that has developed from the transplanted bone marrow stem cells, but this does not mean that the migration of bone marrow stem cells to various tissues for regeneration or repair occurs under normal circumstances.

A stem cell is a cell that has the ability to turn itself into various types of mature cells. Bone marrow stem cells typically turn into red blood cells, different types of white blood cells, and platelets. Somatic (non-bone marrow stem cells) are found in many body tissues and have the ability to develop into different types of mature cells depending upon what is needed.

Interestingly, because stem cells have a greater capacity for sustained replication than other cells, they are being implicated in the development of cancer. It is therefor rather ridiculous to assume that stem cells are some sort of magic bullet to prevent cancer or other diseases.

Having put forth the hypothesis that bone marrow stem cells migrate to other tissues for repair purposes, Drapeau subsequently published an article showing that volunteers given 1 gram of blue-green algae had been found to have an increased number of bone marrow stem cells in their blood stream. This was not a long-term study. The volunteers consumed the algae once and had their blood analyzed. An increased number of circulating blood cells was found, peaking 60 minutes after the algae was taken. From this limited data Drapeau extrapolates that every 1 gram of blue-green algae will potentially cause the release of a few billion cells that will migrate to target tissues.

Unanswered, but important, questions remain:

Is the release of bone marrow stem cells into the blood stream positive or a negative? Will it increase the risk of cancer development? Will it adversely affect the number of mature red cells, white cells, and platelets?

Does the observed release of bone marrow stem cells after consumption of blue green algae mean that the algae is beneficial, or is it a stress response to the algae or an unrecognized contaminant?

If the release is beneficial, is it sustained, or does the number of stem cells released decrease with subsequent servings? Is there any long term response that might justify ongoing consumption of the product?

Do extracts from aphanizomenon flos-aquae carry the same risks of contamination as whole blue-green algae? This must be documented by independent laboratory analysis, and I have been unable to find any evidence that this is routinely performed on each lot of the product.

People love magic pills, gimmicks & slick web sites, even when they may be hazardous to their health. I have to give Stem Enhance's creators credit - not everyone could turn a potentially deadly pond scum into the cure-for-all-diseases.

The reponse of Christian Drapeau, Chief Science Officer of StemTech HealthSciences, Inc., to my previous post (which is available in the archives) is given here in its entirety.

My comments are presented in blue.

Dr. Dale

Dr. Peterson:

I hope this finds you well. I was recently sent a copy of your latest posting on StemEnhance. I did some research on you and discovered that you are, if I am not mistaken, the Dr. Peterson who worked on the famous fossilized finger found in strata alongside dinosaur fossils. Very fascinating work. The whole field of “archeological anomalies” is indeed quite interesting.

My letter is to provide you with some information that you obviously do not have or have not sought. From what I can read, the research you have done before writing this piece was not very extensive. I will provide you with a lot of information that will give you a very different perspective. After perusing this information, you will have one week to remove your posting and retract in the manner you will find honest and ethical. If this does not take place, I will publicly respond to your letter, which will expose at least the disrespect you are showing your readers by offering them inaccurate information based on very poor research, if not clear dishonesty by painting a disparaging picture of the work I am doing. As we all work to increase the health of the American people, I would prefer to preserve your credibility.

1- Sales of blue-green algae did not go down because of some contaminant found in blue-green algae. Sales began to go down and continued to go down nearly one year before the events that misrepresented the so-called toxicity. The cause was essentially mismanagement within Cell Tech at the time. I was the front person dealing with the Oregon Department of Agriculture at the time, so I know the story in the most intricate details. The FDA in Washington never saw any problem in the situation. It was the zeal of a local official at the Oregon Health Division that drove a non-issue into a media frenzy. After 30 years of blue-green algae presence on the marketplace, there is not one documented case of reported so-called toxicity by blue-green algae. The testimonials of two experts in this field, Dr. Wayne Carmichael, Professor of Toxicology and expert in cyanotoxins at Wright State University, and Dr. Gary Flamm, former Head Toxicologist at the FDA in Washington, are present in the public files of the Oregon Department of Agriculture, both testifying to the safety of blue-green algae. This zealous person at the Oregon Health Division, who of his own admission strongly disagreed with the benefits of dietary supplements – any dietary supplement – decided to make a big story out of nothing.

I submitted your statement that there is not one documented case of reported so-called toxicity by blue-green algae to Dr. Milena Bruno, a leading authority on the toxicity of blue-green algae. This was her reply:

Dear Dr. Peterson,

I cannot agree with Mr. Drapeau. Apart from human acute toxicities (one of these in Italy, but I knew some cases in USA in the eighties' due to Klamath pills), the real concern with these BGA products is the microcystin pattern present in the Klamath algae.

Microcystin-LA is often one of the two main toxins present, while MC-LR, MC-RR and MC-YR are the only toxins entirely "seen" by the ELISA immunologic methods used by the firms laboratories of control. This can lead to heavy underestimates of the total microcystin content in these products, if analyses are not performed on LC/MS/MS.

Microcystins have several chronic consequences, they are clastogenic, strong tumor initiators and promoters, they are also endocrine disruptors, and their effects are synergistic.

On the other hand, no serious studies exist (in vitro or in vivo) on the supposed positive effects of these products.

Other troubles may come from BMAA and neurologic pathologies.

Best wishes

Milena Bruno

At the time their testimonies were given, Doctors Carmichael and Flamm did not have access to the data we have today. A more contemporary review paints a much somber picture: Dietrich D, Hoeger S. Guidance values for microcystins in water and cyanobacterial supplement products (blue-green algal supplements): a reasonable or misguided approach? Toxicol Appl Pharmacol. 2005 Mar 15;203(3):273-89. “In reiterating the state-of-the-art toxicology database on microcystins and in the light of new data on the high degree of toxin contamination of algal food supplements, this review clearly demonstrates the need for improved kinetic data of microcystins in humans and for discussion concerning uncertainty factors, which may result in a lowering of the present guidance values."

To summarize your so-called research, you chose to refer to one study by Gilroy et al., Gilroy being the late scientist who so much opposed dietary supplements. In this study he reported that 97 out of 99 samples exceeded the established limit of 1 ppm. What you could not mention because you did not know, as Gilroy misleadingly did not report that in his paper, is that nearly 95 of these samples were collected less than one month after the passing of the regulation. All the bottles then present on the marketplace had obviously been released months before. Such product then complied with the recommendation of a safe limit of 5 ppm, as suggested by both Dr. Carmichael and Dr. Flamm. Later the Oregon Department of Agriculture apologized for the zeal of their official, Dr. Gilroy, and acknowledged 5 ppm as a safe limit. But it was too late, as the regulation had already been passed.

Your statement of Gilroy’s findings is inaccurate. Gilroy tested 87 samples and found microcystins in 83 of them. Only 63 (72 %) contained levels above 1 mcg/g. The other 12 samples I referred to were tested by Saker, et. al. Their laboratory found that 12 of 12 samples obtained from various Internet distributors of BGA contained microcystins.

You may also be interested in knowing that the standard used was 1 mcg/g, not 1 ppm.

One question here for you: If you have done such a thorough research, why have you not also reported the results of the only toxicity trial published on the oral intake of blue-green algae with microcystin, published by Schaeffer et al. (1999) and available on Medline, which showed the total safety of the equivalent of more than 800 capsules of StemEnhance a day?

Given the level of worldwide concern about microcystin toxicity I did not find a solitary 1984 mouse study extrapolated to human levels particularly comforting. I have been a physician for many years and have seen numerous products withdrawn due to toxicity, including death, which had not been detected in animal studies. Since you place great confidence in animal toxicity studies I am sure that you are aware of the work of Zhang, et. al. published in the January 2007 issue of Environmental Toxicology which shows that microcystins not only accumulate in the liver and other tissues of adults, but are passed on to their offspring.

2- The release of stem cells from the bone marrow after consumption of StemEnhance has been clearly evidenced by more than 150 experiments, and such effect has been clearly demonstrated in a double-blind study that has been submitted for publication and shall be published soon. The health benefits of having more stem cells in the blood circulation have been demonstrated by numerous scientific studies. It would be too long here to summarize this vast body of scientific data. I simply suggest you research the work of Dr. Donald Orlic at the NIH.

I am familiar with Dr. Orlic’s work, which primarily surrounds the transfusion of bone marrow stem cells into heart tissue after surgically creating hypoxic conditions. I forwarded your comment and asked him to address the following question:

“I am aware of your work demonstrating the ability of bone marrow stem cells to migrate to the hypoxic heart and regenerate there, but I have not been able to make the connection between your work and the justification for or need to take a bone marrow stem cell releasing product daily under normal circumstances, let alone a product known to contain hepatotoxic microcystins.

In your opinion, should I retract my statement that regular ongoing consumption of BGA dietary supplements, which have regularly been shown to be contaminated with microcystins, carry a risk that does not outweigh the potential benefit? If your work, or other work of which you are aware, has shown the need for daily enhancement of bone marrow stem cells please direct me to those studies.”

Dear Dr. Peterson,

There is a misunderstanding in the comments that Christian Drapeau provided to you. No one, to my knowledge, has ever suggested that there is benefit derived from a daily supplement of a bone marrow stem cell releasing product when administered to normal individuals. You have been misinformed.

Sincerely,

Donald Orlic

3- Your suggestion that StemEnhance is a new name for a pre-existing product in order to counteract sagging sales, is rather petty. The creation of StemEnhance is the honest and rather fascinating pursuit of an understanding of how one product could bring so many benefits in various people. I believe a greater respect should be given to the application of the traditional scientific method when it leads to a rather formidable discovery.

Thank you for clarifying that issue. Actually, I stated that StemEnhance is an extract from AFA, which I, perhaps mistakenly, assumed to be different than most AFA supplements on the market, including that promoted by Cell Tech.

4- Your reference to the lawsuit for wrongful death calls for a reminder that we live in a society that is very prone to lawsuits. As the case will clearly show, there was no link between the consumption of AFA and this unfortunate event. As this is still an open case, I cannot say anything about it. It’s easy to simply throw this kind of information when one intends to disparage a product or a competitor, but your posting unfortunately shows a very poor knowledge of this case.

I do not pretend to have inside knowledge of the case. I do know that a young girl is alleged to have died from liver failure consistent with microcystin toxicity and that microcystins were allegedly found in AFA products in her home. I do not know how the case will turn out, but I do feel that people contemplating daily consumption of an AFA product should know that such allegations exist and that the issue is unsettled.

5- Cell Tech was indeed found guilty of misleading and deceptive claims. But I would recommend that you get the actual transcript of the case and here again do an in-depth research. The defense put by Cell Tech was dismal. I had left Cell Tech shortly before, because I no longer wanted to be part of the unethical business practices that Cell Tech then employed in late 1999. But when I saw the lawsuit, I knew it was frivolous and unfair. The claims could all be backed very solidly, but Cell Tech had no one on staff that could help them build a proper defense. Out of a sense of respect for the truth, I offered my services to Cell Tech to assist them in their defense. It was wrong to allow illegitimate accusations to prevail. But Cell Tech declined my offer, stating that they had a strong defense. Unfortunately, the defense was miserable. In the court transcript we can see the judge trying to help Cell Tech make a case, but the attorneys were quite pathetic. Most of the claims made by Cell Tech are based on sound science, though unfortunately they were not able at the time to formulate such substantiation. But it would be unfair to allow Cell Tech’s incompetence to tarnish a product that brings true health benefits.

As you confirm, Cell Tech was found guilty of making misleading and deceptive claims, and, unless I am mistaken, the verdict has not been overturned. I am aware that Cell Tech is not Stem Tech. The relevance lies in the fact that StemEnhance distributors are beginning to make similar claims for the product. I would hope that individuals considering use of the product would base their decision upon the scientific evidence that Stem Enhance increases hematopoietic stem cell release and not upon unsubstantiated testimonials that suggest it is the cure for all diseases.

6- I, Christian Drapeau, was indeed Director of R&D for Cell Tech from June 1995 to November 1999. During that time I spearheaded all the scientific research done at Cell Tech. When Cell Tech began adopting unethical business practices and lost genuine interest in sound scientific research, I resigned. With a group of other former Cell Tech employees, equally disheartened by Cell Tech growing unethical practices, we created Desert Lake Technologies, where we continued scientific research and created a revolution in harvesting methods, leading to unequaled quality in AFA supplements. You seem to find something reprehensible in this series of events; I see the wonderful story of a group of people guided by a high code of ethics and commitment to quality.

I am pleased to learn that your resignation from Cell Tech and creation of Desert Lake Technologies was based upon a desire to pursue ethical business practices. I trust that those business standards will compel Stem Tech to inform customers that enhanced bone cell release carries potential risks as well as potential rewards.

7- The paper published in Medical Hypothesis is indeed just that, a hypothesis. We never claimed that this was anything but a hypothesis at the time. Your mention that there was nothing to substantiate the claim is an oxymoron. This being said, the following 5 years have supported our hypothesis, which is now an accepted theory. Likewise, our proposal that AFA had an effect on stem cell physiology has been solidly and unequivocally confirmed. This data will soon be published. Had you simply contacted me before writing your letter, I would have shared this data with you and you could have properly honored your readers with some truth.

I look forward to the publication of your research.

8- The fact that stem cells will naturally, under normal circumstances, travel to areas of injury is very well documented at this time, and not just by one study, but by dozens of them, done by numerous independent scientific teams throughout the world. This is definitely one of the greatest recent developments in medical science. I suggest you do a little more honest research. You will discover that stromal or mesenchymal stem cells can become virtually any kind of cell type in the body, including brain, skin, liver, pancreas, lung, muscle, retina, … virtually any type. And not only can they do it, but they do it all the time. Read the work by Krause et al. (2001), Orlic et al. (2001), Kale et al. (2003), and Theise et al. (2002). Hematopoietic stem cells have similar capability; read Lagasse et al. (2000), Camargo et al. (2003), and Corbel et al. (2003). The view you expressed that such stem cells can only become blood cells is an antiquated view, though I must admit this new development has been so rapid that it could have escaped your attention, unless you followed this research very closely. But the literature is very voluminous in this field.

Your comments are based upon a misreading of my article. I am well aware of the ability of bone marrow stem cells to participate in tissue repair in various body tissues. What I stated was that hematopoietic stem cells typically become blood cell components and that there are also somatic stem cells throughout the body. What I intended to convey, and did not clearly state, is that organ-specific somatic stem cells play the primary role in tissue repair and that the role of hematopoietic stem cells is secondary. I feel that it is important for individuals considering the use of a bone marrow stem cell releasing product to understand this distinction.

9- Your mention of the link between stem cells and cancer is another evidence of your limited knowledge of this field. Because cancer cells share a characteristic with stem cells, namely immortality, they have often been referred to as “cancer stem cells” or “stem cell-like cancer cells”. But bone marrow stem cells are not “cancer stem cells”. This is like warning people about house cats because they belong to the same family –felines– as tigers. “Cancer stem cells” are cells at the core of a tumor that are immortal; they have nothing to do with bone marrow stem cells. It has been proposed that some cancer could emerge from tissue stem cells, but this still has nothing to do with bone marrow stem cells. And it remains nothing more than a proposal based on some observations. It is interesting to witness your keenness to transform such observations into a truism while you so adamantly deny and disparage information about StemEnhance that is solid. That’s where politics and personal agenda take over honest science. You can read the good review on the topic by Tan et al., 2006, Laboratory Investigation, 86:1203-1207.

I suggest that you update your understanding of the relationship of bone marrow stem cells to cancer growth. I refer you to the following articles, which are but a few of those readily available:

Xiong-Zhi W, Dan C, Guang-Ru X. Bone marrow-derived cells: roles in solid tumor. Neoplasma. 2007;54(1):1-6. "The role of cancer stem cells has been demonstrated for some cancers. Recently, research indicated that solid tumors may originate from bone marrow stem cells. Bone marrow-derived cells have recently been shown to contribute to stromal formation, especially angiogenesis and lymphvasculogenesis. Moreover, the interaction and the cell fusion between cancer cells and bone mesenchymal stem cells could enhance the aggregative ability of cancer cells. Bone marrow derived cells home to tumor-specific pre-metastatic sites to provide a permissive niche for incoming tumor cells.

Takakura, N. Role of hematopoietic lineage cells as accessory components in blood vessel formation. Cancer Sci. 2006 Jul;97(7):568-74. “It is widely believed that after birth, endothelial cells (EC) in new blood vessels are derived from resident EC of pre-existing vessels. However, evidence is now emerging that cells derived from the bone marrow may also contribute to postnatal angiogenesis. Most studies have focused initially on the contribution of endothelial progenitor cells in this process. However, we have proposed a concept in which cells of the hematopoietic lineage are mobilized and then entrapped in peripheral tissues, where they function as accessory cells that promote the sprouting of resident EC by releasing angiogenic signals. Most recently we found that hematopoietic cells play major roles in tumor angiogenesis by initiating sprouting angiogenesis and also in maturation of blood vessels in the fibrous cap of tumors.”

Varner, JA. Stem cells and neurogenesis in tumors. Prog Exp Tumor Res. 2007;39:122-9. "Bone-marrow-derived and tissue-resident stem cells promote repair of injured tissues by contributing to new blood vessel, muscle and nerve formation. These same stem cells may contribute to tumor growth and spread. Tumors express numerous growth factors that induce both angiogenesis and neurogenesis; these factors may also induce tissue-resident stem cell recruitment and differentiation. Tumors also recruit circulating bone-marrow-derived stem or progenitor cells, which play roles in promoting tumor growth and spread. As innervation of tumors promote cancer pain and can contribute to tumor spread, an understanding of the roles of stem cells in tumor innervation will assist in the development of new cancer therapies."

10- Indeed our double-blind study was not long-term, simply because the effect on stem cells is transient. It would not have made much sense to measure this effect over long periods of time if it is transient. It follows very well known information about stem cells, namely that once released from the bone marrow, stem cells have a transit time in the blood of approximately one hour (6 minutes to 6 hours). The health effect of a transient increase in the number of stem cells in the blood has been, again, well demonstrated. See the work by Werner et al. (2005) or Tomoda et al. (2003).

I was not suggesting a long-term effect of a single dose, but rather confirmation that the effect remained as subsequent doses were taken. Your confirmation that you have done 2 year follow-up studies that demonstrate ongoing enhanced release addresses this issue.

I will correct you on one thing: I never claimed that StemEnhance caused the release of a few billion cells, I don’t know where you got that information. But indeed, the released stem cells can travel to tissues. See the work by Krause et al. (2001), Orlic et al. (2001), Vendervelde et al. (2005), Theise et al. (2003)… the literature is so vast. An honest search shall deliver you plenty of literature.

I quote from your article Triple-Blind Randomized Placebo-Controlled Study of the Effect of StemEnhance on Bone Marrow Stem Cell Mobilization "data exist to estimate the physiological relevance of putting into circulation 3.5 million new stem cells . . . one can estimate that one gram of StemEnhance can lead to potentially of up to a few billion somatic cells in target tissues." If you choose to quibble over the distinction that the release of 3.5 million new stem cells leads to up to a few billion somatic cells, so be it.

I will now answer your questions, which, though you call them unanswered, have for the most part already been answered in the literature:

1. Is the release of bone marrow stem cells into the blood stream positive or negative?

Actually, bone marrow stem cell release is a two-edged sword. While they can participate in the healing process, it is becoming clear that they can also predispose to cancer development and promote more aggressive cancer growth and increase the risk of metastases. See references in my comments to section 9 above.

2. Will it increase the risk of cancer development?

There is no documentation of cancer promotion by bone marrow stem cells. Quite the contrary; there is an increasing number of reports of cancer regression after stem cell injection or stem cell enhancement, though studies have yet to be done in this area. But without data, I will abstain from making any claim. The confusion comes from the fact that some cancer cells share characteristics with stem cells and have therefore been termed “stem cell-like cancer cells”. They essentially share immortality and the ability to become all the cell types of their tissue of origin. But that has nothing to do with bone marrow stem cells.

I refer you back to the articles posted above on the role of bone marrow stem cells in the development, growth, and metastasis of cancerous tumors.

3. Will it adversely affect the number of mature red cells, white cells, and platelets?

The level of all types of white blood cells, red blood cells and platelets is unaffected by StemEnhance, neither on the day of consumption nor after long-term consumption. This was tested.

I am pleased to learn that you have testing this aspect of the product.

4. Does the observedrelease of bone marrow stem cells after consumption of blue-green algae mean that the algae is beneficial, or is it a stress response to the algae or an unrecognized contaminant?

The mechanism of action has been well demonstrated and documented. It has nothing to do with a contaminant. StemEnhance contains an L-selectin ligand, a type of compound known to trigger stem cell mobilization from the bone marrow; see the work of Frenette et al. (2000). This kind of comment suggests either dishonesty or a very poor scientific method on your part. Why, in the absence of a deeper understanding on your part, is the presence of an “unrecognized” contaminant the only alternative explanation you can offer for this phenomenon?

Thank you for clarifying this point.

5. If the release is beneficial,is itsustained, or does the number of stem cells released decrease with subsequent servings?

The effect was tested on new consumers and on people who had been consuming StemEnhance for nearly 2 years, and AFA for nearly 10 years. If anything, the effect seems to increase with time. It definitely does not decrease.

Thank you. This answers the question.

6. Is there any long termresponse thatmight justifyongoing consumption of the product?

I am not sure I understand the question. I believe that if someone experiences great health benefits by taking StemEnhance over the long term, this could be reason enough to justify ongoing consumption.

I know that you are convinced, on the basis of your research, that daily consumption of AFA provides multiple benefits. I am not debating that point. There are, however, many who believe as I do that most, if not all, of the benefits attributed to AFA can be obtained by consuming supplements that do not contain any microcystins.

Given that the overwhelming majority of studies on the role of bone marrow stem cells in repair functions center around conditions of acute hypoxia and expansion, I remain unconvinced that daily consumption of the product in normal individuals is justified. On this point Dr. Orlic, whose work you endorse, and I agree, as does Dr. Bruno. Their statements are given in full earlier in this document.

7. Do extracts from Aphanizomenon flos-aquae carry the same risks of contamination as whole blue-green algae?

The so-called risk of AFA has been addressed above. StemEnhance carries the same safety as AFA and is tested in a manner that establishes it as one of the safest dietary supplements on the marketplace.

I accept that StemEnhance carries the same safety and risk as other AFA products. Please refer back to Dr. Bruno's comments provided under Section 1 in this regard.

8. This must be documented by independent laboratory analysis, and I have been unable to find anyevidence that this is routinely performed on each lot of the product.

Every day of harvest is tested for possible contaminants and every lot of StemEnhance is thoroughly tested for pesticides, heavy metals, possible microbial contaminants, and even radioactivity to satisfy some international requirements. All this testing is performed by outside independent laboratories. This information is not public; to obtain it you simply had to ask for it. Its absence from the public domain does not mean its existence.

You may not be able to appreciate this at this time, but I believe the credit we deserve is to have discovered a physiological reality about the role of stem cells in the body that will revolutionize the way we view health and medicine. But like so many other things, this concept will find acceptance, as it already does, in people with open and honest minds, not in people intent on discrediting it without having done the slightest research.

Open and honest scientific minds must consider the potential for adverse outcomes as well as beneficial ones when considering whether to move ahead with new technologies. The emerging evidence that bone marrow stem cells not only have the potential to augment the action of somatic stem cells in repair of tissue injury but also play a role in cancer development, aggressiveness, and metastasis should be cause for concern about the wisdom of promoting the effect to a wide population at this time.

A summary of all this information is contained in a written testimonial that we requested from an independent stem cell expert, to ensure that we were not making improper claims about StemEnhance. This testimonial supports all of our claims, both on StemEnhance and on the role of bone marrow stem cells in the body.

Perhaps a wider array of testimonials from independent stem cell experts, particularly those engaged in research designed to prevent the role of bone marrow stem cells in tumor angiogenesis and neurogenesis should be solicited, to ensure that prospective consumers are able to make a fully informed decision. Dr. Donald Orlic's comment that he knows of no evidence support the benefit of a bone marrow stem cell releasing product is found under Section 2 above. Dr. Milena Bruno's statement is reported under Section 1 above.

I will conclude by quoting the French philosopher Montaigne: “It is a silly presumption to criticize and condemn as false what does not seem likely, though this is a common vice of those who see themselves as above the common man. It is one of the greatest follies of our world to bring down things to the level of our ignorance and arrogance, and to despise what we cannot understand.”

I wholeheartedly agree. I can appreciate how your life-long pursuit of the benefits of AFA may have at least partially blinded you to the potential risks of promoting its widespread consumption. I encourage you to address your lack of understanding of the role of bone marrow stem cells in cancer and humbly seek the opinions of those who better understand the complexities of this emerging technology.

As previously mentioned, if your deceptive posting is still on your website one week from receipt of this letter, we will make our comments public.

I have posted your comments in totality, without any change whatsoever.